Back to resultsEvaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Respironics Synchrony ventilator (Non Invasive Ventilation)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
Inclusion Criteria
- Age < 80 years
- Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)
- Free from any exacerbation in the 6 weeks preceding the study
Exclusion Criteria
- Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome
- Clinically unstable; exacerbation within the preceding 6 weeks
- The presence of pulmonary or extra-pulmonary neoplasia that is still active
- The presence of a bleeding diathesis
- Unstable coronary artery disease
- Presence of tuberculosis, current infection or potentially infectious pathogen
- Inability to provide informed consent to the study
Sites / Locations
- University Hospital Aintree
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Respironics Synchrony ventilator (Non Invasive Ventilation)
Arm Description
Non Invasive Ventilation using forced oscillation technique (FOT)
Outcomes
Primary Outcome Measures
Detection of Expiratory Flow Limitation
Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).
Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).
Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.
Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator
Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique
Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151618
Brief Title
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
Official Title
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique.
Detailed Description
Positive end expiratory pressure (PEEP) is used in COPD patients to counteract the intrinsic PEEP (PEEPi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (DH).
DH commonly occurs in COPD, where the presence of expiratory flow-limitation (EFL) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting EFL expiratory flow. To be effective, the PEEP level applied to the patient should be equal to PEEPi.
The continuous monitoring of EFL could be a useful tool to select the minimum PEEP level required to abolish it.
EFL can be detected using the forced oscillation technique (FOT) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta Xrs) at 5Hz.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respironics Synchrony ventilator (Non Invasive Ventilation)
Arm Type
Experimental
Arm Description
Non Invasive Ventilation using forced oscillation technique (FOT)
Intervention Type
Device
Intervention Name(s)
Respironics Synchrony ventilator (Non Invasive Ventilation)
Intervention Description
Non Invasive Ventilation using forced oscillation technique (FOT)
Primary Outcome Measure Information:
Title
Detection of Expiratory Flow Limitation
Description
Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).
Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).
Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.
Time Frame
within 2 hours
Title
Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator
Description
Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.
Time Frame
2 hours
Title
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique
Description
Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.
Time Frame
2 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age < 80 years
Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)
Free from any exacerbation in the 6 weeks preceding the study
Exclusion Criteria
Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome
Clinically unstable; exacerbation within the preceding 6 weeks
The presence of pulmonary or extra-pulmonary neoplasia that is still active
The presence of a bleeding diathesis
Unstable coronary artery disease
Presence of tuberculosis, current infection or potentially infectious pathogen
Inability to provide informed consent to the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Calverley, Professor
Organizational Affiliation
Aintree University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aintree
City
Liverpool
ZIP/Postal Code
L97AL
Country
United Kingdom
12. IPD Sharing Statement
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Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
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